FDA 510(k) Application Details - K180209

Device Classification Name	Assay, 1,5-Anhydroglucitol (15ag)   More FDA Info for this Device
510(K) Number	K180209
Device Name	Assay, 1,5-Anhydroglucitol (15ag)
Applicant	Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92130 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	NOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2018
Decision Date	10/04/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review